Summary
Amlodipine Besylate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. ClinicalTrials.gov lists 8 registered trials linking Amlodipine Besylate to Hypertension: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00819104). The largest enrolment is 965 participants (NCT00699192). Registration activity spans 2008 to 2020. The literature layer holds 10 publications for this pair: 1 Cochrane review, 2 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2006 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Essential Hypertension ranks 376 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not well-characterized as population baseline; routinely framed as irreversible in clinical culture despite contrary trial evidence.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 79.0 (trials 30.0, literature 29.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 10 (5 clinical trial publications, 2 meta-analyses, 1 Cochrane review, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00819104 | A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components 2008 | completed | Phase 4 | 402 |
| NCT00765947 | Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension 2008 | completed | Phase 4 | 256 |
| NCT01241487 | A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy 2009 | completed | Phase 4 | 150 |
| NCT01237873 | Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension 2011 | completed | Phase 3 | 150 |
| NCT00699192 | Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension 2008 | completed | Phase 3 | 965 |
| NCT03991442 | BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination 2019 | completed | Phase 3 | 257 |
| NCT01340131 | CKD-828 (40/5mg) Pharmacokinetic Study 2011 | completed | Phase 1 | 68 |
| NCT04554303 | Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension 2020 | status unknown | Not applicable | 80 |
Published literature
- Clinical trial publication Effects of Two Allisartan Isoproxil-Based Antihypertensive Therapies on Sexual Function and Blood Pressure in Male Hypertensive Patients: A Single-Center, Open-Label, and Randomized Controlled TrialWang M, Chen J, Qi M et al. · Journal of clinical hypertension (Greenwich, Conn.) · 2025 · PMID 40965515
- Clinical trial publication Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled TrialWang F, Gao HQ, Lyu Z et al. · Chinese journal of integrative medicine · 2025 · PMID 39551851
- Clinical trial publication Effect and mechanism of HMG-CoA reductase inhibitor on the improvement of elderly essential hypertension-induced vascular endothelial function impairment based on the JAK/STAT pathwayYuan W, Fan H, Yang H et al. · Diagnostic pathology · 2023 · PMID 37759223
- Clinical trial publication Efficacy of Allisartan Isoproxil in the Treatment of Mild-to-Moderate Essential HypertensionWang H, Xi Y, Chen Y et al. · American journal of hypertension · 2023 · PMID 37343187
- Clinical trial publication Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness StudyMa W, Sun N, Duan C et al. · Cardiovascular drugs and therapy · 2021 · PMID 32915349
- Cochrane review Efficacy of amlodipine besylate and Valsartan for the treatment of mild to moderate hypertensionWang XO, Tian W · Medicine · 2019 · PMID 31261595
- Randomized controlled trial Effects of triple combination therapy with azilsartan/amlodipine/hydrochlorothiazide on office/home blood pressure: a randomized-controlled trial in Japanese essential hypertensive patientsRakugi H, Shimizu K, Sano Y et al. · Blood pressure monitoring · 2018 · PMID 29239867
- Systematic review Perindopril arginine and amlodipine besylate for hypertension: a safety evaluationElliott WJ, Bistrika EA · Expert opinion on drug safety · 2018 · PMID 29065722
- Meta-analysis Amlodipine and cardiovascular outcomes in hypertensive patients: meta-analysis comparing amlodipine-based versus other antihypertensive therapyLee SA, Choi HM, Park HJ et al. · The Korean journal of internal medicine · 2014 · PMID 24851066
- Meta-analysis A review of the efficacy of fixed-dose combinations olmesartan medoxomil/hydrochlorothiazide and amlodipine besylate/benazepril in factorial design studiesQuan A, Chavanu K, Merkel J · American journal of cardiovascular drugs : drugs, devices, and other interventions · 2006 · PMID 16555863
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Amlodipine Besylate approved for Hypertension?
Amlodipine Besylate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Amlodipine Besylate in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Amlodipine Besylate to Hypertension: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00819104). The largest enrolment is 965 participants (NCT00699192). Registration activity spans 2008 to 2020.
What does the evidence show for Amlodipine Besylate in Hypertension?
Amlodipine Besylate has both completed registered trials and synthesis-level publications linked to Hypertension. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.